Some of the most important questions in emergency care can only be answered during the first minutes after a life-threatening illness or injury. In these circumstances, patients may be unconscious or critically ill, legally authorized representatives may not be available, and delaying treatment to obtain prospective informed consent may make the research—and the opportunity to improve care—impossible.
Federal regulations therefore allow carefully regulated emergency research to be conducted under Exception from Informed Consent (EFIC) when specific requirements are met.
The UAB Center for Injury Science has more than two decades of experience conducting EFIC research. More recently, our work has focused not only on conducting EFIC trials, but on transforming how the community consultation and public disclosure required for these trials can be performed at scale.
Transforming Community Consultation and Public Disclosure
Community consultation and public disclosure (CC/PD) are central safeguards in EFIC research. Before an EFIC trial begins, investigators must engage with communities in which the research will take place, provide information about the proposed study, solicit feedback, and publicly disclose information about the research.
Historically, this has relied heavily on approaches such as in-person community meetings, telephone surveys, newspaper advertisements, and other locally organized activities. These approaches can be slow, expensive, labor intensive, difficult to standardize across sites, and limited in the number and diversity of community members they reach.
CIS developed a different approach.
Our interactive media-based model for CC/PD combines geographically targeted digital outreach with locally branded study websites, structured community surveys, interactive online community meetings, opportunities to ask questions and provide feedback, and mechanisms for individuals to opt out of participation when appropriate.
Importantly, the approach allows these activities to be centrally coordinated while remaining locally focused. Each participating center engages the communities it actually serves, but the infrastructure, materials, processes, data collection, analysis, and reporting can be coordinated centrally.
This model makes it possible to conduct rigorous CC/PD across dozens of sites simultaneously—something that was extremely difficult using traditional approaches.
Demonstrating That the Model Works
The approach was developed and refined through CIS's experience with emergency research and was deployed at unprecedented scale for the TAP Trial, a large multicenter EFIC trial involving trauma centers throughout the United States.
In an analysis of the first 52 participating TAP sites:
- Digital advertisements were displayed approximately 92 million times
- 11.8 million people were reached
- Study websites received more than 144,000 views
- More than 17,000 community surveys were completed, in whole or in part
- Each participating site had a geographically targeted and locally branded campaign
- CIS centrally coordinated the campaigns and produced site-specific reports for regulatory review
The work demonstrated that a single coordinating center could conduct efficient, standardized CC/PD across a large national EFIC trial while preserving meaningful engagement with individual local communities.
The results were published in JAMA Surgery in 2024 and provided an evidence base for a new approach to one of the most challenging aspects of multicenter emergency research.
From Innovation to National Infrastructure
What began as a solution to a problem encountered in our own trials has subsequently developed into a resource for the wider emergency research community.
CIS now provides centralized CC/PD expertise and infrastructure for multicenter EFIC trials conducted across the United States. Current and recent collaborations include KESETT, WINDSURFER, Pedi-PART, and MATIC-2, spanning emergency neurology, respiratory failure, pediatric emergency care, and traumatic hemorrhage.
Rather than requiring every participating institution to develop an independent community consultation strategy from the ground up, a coordinated approach allows trial networks to use common materials, methods, data systems, analytic approaches, and reporting structures while retaining site-specific community engagement.
The result is a model that is scalable, reproducible, measurable, and adaptable to different communities and different types of emergency research.
Community Engagement, Not Simply Advertising
Reach alone is not community consultation.
Our work therefore goes beyond disseminating information about a clinical trial. The goal is meaningful two-way engagement: explaining why the research is being proposed, assessing whether information has been understood, eliciting community views and concerns, answering questions, identifying differences among communities, and providing those findings to investigators and Institutional Review Boards.
Digital approaches also generate measurable information about who has been reached, how communities interact with study materials, what questions or concerns arise, and how attitudes toward emergency research vary across populations and locations.
This creates an opportunity not merely to make CC/PD more efficient, but to study and continuously improve the process itself.
Advancing the Science of EFIC
CIS continues to investigate fundamental questions about how emergency research should be conducted.
How should a relevant “community” be defined? Who should be consulted? How do we determine whether consultation is sufficiently representative? How much information do community members need? How should understanding be assessed? Which approaches best reach populations that have historically been underrepresented in research? And how should community feedback influence the decision to conduct a trial?
These questions are important because federal regulations intentionally do not prescribe a single method or numerical threshold for adequate community consultation.
By embedding rigorous evaluation within real-world EFIC trials, CIS is helping build an evidence base for answering these questions and for improving the ethical and scientific conduct of emergency research.
Supporting Multicenter EFIC Trials
CIS works with academic investigators, clinical trial networks, government agencies, industry partners, Institutional Review Boards, and participating clinical sites to develop and implement CC/PD strategies for multicenter emergency research.
Our capabilities include development of CC/PD strategy and materials; geographically targeted community outreach; study-specific websites and digital engagement; community surveys; virtual community meetings; centralized data collection and analysis; site-specific regulatory reporting; public disclosure; and coordination with participating sites and central and local IRBs.
For investigators planning an EFIC trial, early engagement is particularly valuable. Community consultation should be considered as part of trial design and implementation—not as a regulatory exercise added immediately before enrollment.
Improving Emergency Research
EFIC makes it possible to answer clinical questions that otherwise could not be studied—and to improve treatments for patients who are often at their most vulnerable.
Our goal is to ensure that this research can be conducted efficiently, rigorously, transparently, and with meaningful involvement of the communities it is intended to serve.
Through the development of scalable community-engagement methods, their evaluation in large multicenter trials, and their application across national research networks, the UAB Center for Injury Science is helping define a new model for the conduct of EFIC research.